Diclofenac Sodium/Misoprostol

Product NDC: 42571-134
11-digit product format: 425710134
Labeler code: 42571
Product ID: 42571-134_3afc5367-562f-b4a0-e063-6294a90a2560
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium/Misoprostol
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA204355
Marketing category: ANDA
Marketing start: 2021-09-01
Substance: DICLOFENAC SODIUM; MISOPROSTOL
Active strength: 75; 200 mg/1; ug/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-07-15
A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-07-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204355-001	AB
A204355-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204355-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204355-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204355-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204355-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204355-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204355-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204355-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204355-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204355-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204355-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204355-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204355-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204355-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204355-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204355-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204355-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-002	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium/Misoprostol
Brand name suffix: DICLOFENAC-SODIUM-MISOPROSTOL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	75 mg/1
MISOPROSTOL	200 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0E43V0BB57	Internal UNII lookup
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857706	Internal RxNorm lookup
1359105	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9	Product name	3	20231221
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42571-134-29	Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL	60 in 1 CARTON	TABLET	60	9
42571-134-29	Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL	10 in 1 BLISTER PACK	TABLET	10	9
42571-134-30	Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL	30 in 1 BOTTLE	TABLET	30	9
42571-134-60	Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL	60 in 1 BOTTLE	TABLET	60	9
42571-134-90	Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL	90 in 1 BOTTLE	TABLET	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-134-60	EA - Each	42571-134	162532c5-8bd4-4586-be96-2ad6e4a7e464	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-134	DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL (DICLOFENAC SODIUM/MISOPROSTOL) TABLET [MICRO LABS LIMITED]	8	Current NDC, Legacy NDC, 5 package rows	20241205_c61df58d-d6bb-4d3e-9ef8-60caa7d4e762.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Sportpharm LLC	0d6509a1-7af8-473b-8951-c19439274379	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Micro Labs Limited	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355 ndc (product): 42571-134
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Bryant Ranch Prepack	7225385c-501c-4e90-8948-8617d583108c	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
DICLOENAC SODIUM and MISOPROSTOL DR	DICLOENAC SODIUM AND MISOPROSTOL	Advanced Rx Pharmacy of Tennessee, LLC	f4d8c198-63e1-3109-e053-2995a90acad9	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM
0E43V0BB57	MISOPROSTOL	59122-46-2	MISOPROSTOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857706	diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
857706	diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
857706	diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
857706	diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	9
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	f4d8c198-63e1-3109-e053-2995a90acad9	2
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	f4d8c198-63e1-3109-e053-2995a90acad9	2
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	f4d8c198-63e1-3109-e053-2995a90acad9	2
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	f4d8c198-63e1-3109-e053-2995a90acad9	2
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	7225385c-501c-4e90-8948-8617d583108c	1
1359105	diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet	PSN	0d6509a1-7af8-473b-8951-c19439274379	1
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	7225385c-501c-4e90-8948-8617d583108c	1
1359105	diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet	SCD	0d6509a1-7af8-473b-8951-c19439274379	1
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	7225385c-501c-4e90-8948-8617d583108c	1
1359105	diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet	SY	0d6509a1-7af8-473b-8951-c19439274379	1
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	7225385c-501c-4e90-8948-8617d583108c	1
1359105	diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet	SY	0d6509a1-7af8-473b-8951-c19439274379	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-134-29	42571013429	60 BLISTER PACK in 1 CARTON (42571-134-29) / 10 TABLET in 1 BLISTER PACK	60 blister pack	2021-09-01	0000-00-00	No	No	Current
42571-134-30	42571013430	30 TABLET in 1 BOTTLE (42571-134-30)	30 tablet	2021-09-01	0000-00-00	No	No	Current
42571-134-60	42571013460	60 TABLET in 1 BOTTLE (42571-134-60)	60 tablet	2021-09-01	0000-00-00	No	No	Current
42571-134-90	42571013490	90 TABLET in 1 BOTTLE (42571-134-90)	90 tablet	2021-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	Sportpharm LLC	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	Micro Labs Limited	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	9
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	Bryant Ranch Prepack	2025-06-04	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol	Preferred Pharmaceuticals Inc.	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	4
Diclofenac Sodium and Misoprostol 75mg/200mcg DR Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-02-23	HUMAN PRESCRIPTION DRUG LABEL	2